Visitor Monitoring Drug History: DANOCRINE
 
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Label and Approval History

Drug Name: DANOCRINE
FDA Application No: (NDA) 017557
Active Ingredient(s): DANAZOL
Company: SANOFI AVENTIS US
 
Label History
 
Labels are not available on this site for DANOCRINE, (NDA) 017557
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/19/1996 035Control Supplement  
5/2/1994 032Labeling Revision  
1/28/1994 031Labeling Revision  
8/2/1995 030Package Change  
3/1/1993 029Labeling Revision  
7/5/1990 028Labeling Revision  
5/2/1988 027Control Supplement  
3/24/1986 026Labeling Revision  
1/29/1985 025Labeling Revision  
8/9/1984 023Labeling Revision  
8/9/1984 022Labeling Revision  
8/9/1984 021Labeling Revision  
1/22/1982 016Control Supplement  
11/1/1982 015Labeling Revision  
11/3/1980 014Labeling Revision  
5/29/1980 013Package Change  
6/3/1980 012Manufacturing Change or Addition  
3/31/1980 011Package Change  
5/18/1981 010General Efficacy (MarkIV)  
10/25/1979 009Control Supplement  
9/2/1980 006General Efficacy (MarkIV)  
5/31/1978 005Manufacturing Change or Addition  
3/14/1978 004Labeling Revision  
3/23/1978 003Formulation Revision  
9/27/1976 001Labeling Revision  
6/21/1976 000Approval  
 
Therapeutic Equivalents
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